Inova Diagnostics, Inc.
Inova Diagnostics, Inc. appears in FDA public data with 0 recalls, 138 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Feb 6, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 138
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K243979 | Aptiva APS IgA Reagent | Feb 6, 2026 |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Dec 17, 2024 |
| K213403 | Aptiva CTD Essential Reagent | Sep 29, 2023 |
| K200230 | Aptiva Celiac Disease IgG Reagent | Aug 26, 2021 |
| K193604 | Aptiva Celiac Disease IgA Reagent | Jun 16, 2021 |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | Dec 11, 2020 |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | Apr 17, 2019 |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | Oct 16, 2018 |
| K180975 | QUANTA Flash HMGCR Reagents | Jun 25, 2018 |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin | Dec 22, 2017 |
| K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | Sep 6, 2017 |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls | Sep 5, 2017 |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit | Feb 3, 2017 |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls | Jun 1, 2016 |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | Apr 11, 2016 |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols | Feb 12, 2016 |
| K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1 | Dec 21, 2015 |
| K153150 | AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 | Nov 24, 2015 |
| K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 | Sep 21, 2015 |
| DEN140039 | NOVA View Automated Fluorescense Microscope | Apr 9, 2015 |